Methods, devices, and systems for moving a fluid along a fluid path for treatment

ABSTRACT

The devices and systems are medical fluid treatment therapies. The device and systems are configured and capable of operating based on small volumes of fluids. The devices and systems include a pump configured for small volume of a fluid. The pump may include a first conduit configured for inflow of the fluid; a second conduit configured for outflow of the fluid; a fluid chamber configured to move the fluid through the pump; a diaphragm configured to force the fluid through the fluid chamber by indirectly exerting force on the fluid chamber; and a connector configured to removably attach the pump to a motor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 13/218,328filed Aug. 25, 2011, allowed, which claims the benefit of priority toU.S. Provisional Application No. 61/376,720 filed Aug. 25, 2010. Theapplications are hereby incorporated by reference in their entireties.

ACKNOWLEDGEMENTS

This invention was made with government support under Grant No.1RC1DK086939 awarded by National Institute of Diabetes and Digestive andKidney Diseases (National Institutes of Health). The government hascertain rights in the invention.

FIELD

This disclosure relates to devices and systems for medical fluidtreatment therapies. More particularly, the disclosure relates todevices and systems for extracorporeal blood treatment having accuratefluid management of small volumes.

BACKGROUND

Medical fluid treatment therapies are generally used to treat loss ofrenal function or renal failure. A person's renal system can fail due todisease, injury or other causes, such as complications associated withextracorporeal membrane oxygenation (ECMO) treatment. During renalfailure or loss of renal function, toxic end products of metabolism(e.g., urea, creatinine, uric acid, and others) can accumulate in bloodand tissues because the balance of water, minerals and the excretion ofdaily metabolic load can be reduced or no longer possible.

Renal support can be provided by a continuous renal replacement therapy(CRRT), such as continuous venovenous hemofiltration (CVVH) orcontinuous venovenous hemodiafiltration (CVVHDF). These therapies aredesigned to remove metabolic waste and excess fluid from patient influid overload and those who need renal support. These therapies allowprovide continuous fluid, electrolyte and toxin clearance even in theabsence of adequate native renal function via convective or dialyticprocesses through a permeable membrane.

CRRT is a common renal replacement therapy for critically ill andhemodynamically unstable patients in the pediatric intensive care unit.However, there is currently no FDA approved CRRT device for use in theneonatal and pediatric populations. Generally, physicians resort toutilizing devices approved for adults to treat children. The adultapproved CRRT devices are not designed for the smaller volumes inherentin treating children.

SUMMARY

Thus, there is a need for devices capable of handling a smaller fluidvolume, such as in the pediatric patient. The disclosure relates todevices and systems for medical fluid treatment. These devices andsystems are configured for small fluid volume and allow operatingparameters for a small fluid volume.

According to some embodiments, the disclosure may relate to a fluid pumpfor medical fluid treatment therapies configured for small volumes of afluid. The pump may include a first conduit configured for inflow of thefluid; a second conduit configured for outflow of the fluid; a fluidchamber configured to move the fluid through the pump; a diaphragmconfigured to force the fluid through the fluid chamber by indirectlyexerting force on the fluid chamber; and a connector configured toremovably attach the pump to a motor.

According to some embodiments, the fluid pump may include a pistonconnected to the diaphragm, the piston configured to linearly move asurface, the diaphragm.

The fluid pump may include a housing, the housing including at least afirst section and a second section. The first section may include acavity filled with an incompressible fluid, the first conduit, thesecond conduit and the fluid chamber, and the cavity is disposed betweenthe fluid chamber and the diaphragm. According to other embodiments, thediaphragm may be fixedly attached to the housing between the firstsection and the second section. The diaphragm may also be configured tomove between a first position and a second position; the first positioncorresponding to when a surface of the diaphragm protrudes into thefirst section and the second position corresponding to when the surfaceof the diaphragm protrudes into the second section. According to someembodiments, the diaphragm may be configured to transfer force to theincompressible fluid when the diaphragm is in the second position, andthe incompressible fluid is configured to move the fluid through thefluid chamber.

According to some embodiments, the second section may include a piston.According to some embodiments, the first section may have an extendingsurface and the second section has an extending surface, the extendingsurface of the first section facing the extending surface of the secondsection. According to further embodiments, the pump may include a cap,the cap including ports configured to connect tubing to the first andsecond conduits.

According to some embodiments, the disclosure may relate to a medicalfluid therapy system. The system may include at least one medical fluidpump, the pump including: a fluid chamber configured to move a fluidthrough the pump; a diaphragm configured to force the fluid through thefluid chamber by indirectly exerting force on the fluid chamber; aplurality of valves, the valves including at least a first valve and asecond valve configured to control the flow of fluid through the fluidpump; a motor; and a controller configured to collectively control themovement of the motor and valves with respect to each other.

According some embodiments, the system may include: a fluid balancesystem; the fluid balance system including a first pump and a secondpump, each pump including the fluid chamber, the rolling diaphragm andthe first valve and the second valve; wherein the first pump and secondpump are offset of each other.

According to some embodiments, the system may further include a display;the display includes a user interface configured to enter operatingparameters to control the system. The user interface may display theoperating status of the system. The operating status may include flowrates of the fluid flowing through the pump and the angle of the valve.

According to some embodiments, the system may include at least one pumpreceiving member, the at least one pump receiving member having andepression configured to receive a portion of the pump, wherein the pumpincludes a housing, the housing including at least a first section and asecond section, wherein the first section has an extending surface andthe second section has an extending surface, the extending surface ofthe first section facing the extending surface of the second section,and wherein the depression is configured to receive the extendingsurface of at least the second section.

According to some embodiments, the system may include at least first andsecond self-contained sections, wherein the first section includes thecontroller; and the second section includes the pump receiving member.The system may also be configured for a plurality of fluid treatmentmodes. The controller may be configured to control the motor and valvesbased on entered volume parameters or selected treatment modes.According to some embodiments, an operating status of the system may bestored at predetermined intervals.

According to some embodiments, the system may be configured to beconnected to another medical fluid treatment therapy device. In someembodiments, the controller may control the system based on the othermedical fluid treatment therapy or extracorporeal treatment systems anddevices. The other medical fluid treatment device may include at leastone of an ECMO device, cardiopulmonary bypass device, ventricular assistdevice, plasma exchange device, apheresis device, or hemoperfusiondevice. According to some embodiments, the controller may control thesystem based on a selected mode, connected therapy device, adjuncttherapy, patient type, or any combination thereof. The controller maycontrol at least one operating parameter based on the selected mode,connected therapy device, adjunct therapy, patient type, or anycombination thereof.

According to other embodiments, the disclosure may relate to adisposable kit for a medical therapy system. The disposable kit mayinclude a first conduit configured for inflow of the fluid; a secondconduit configured for outflow of the fluid; a fluid chamber configuredto move the fluid through the pump; a diaphragm configured to force thefluid through the fluid chamber by indirectly exerting force on thefluid chamber; and a connector configured to removably attach the pumpto a motor.

In some embodiments, the kit may include tubing configured for themedical therapy system.

DESCRIPTION OF FIGURES

The disclosure can be better understood with the reference to thefollowing drawings and description. The components in the figures arenot necessarily to scale, emphasis being placed upon illustrating theprinciples of the disclosure.

FIG. 1 is a schematic diagram of a medical fluid treatment systemaccording to some embodiments;

FIG. 2 is a schematic representation of the fluid systems of a medicalfluid treatment system according to some embodiments;

FIG. 3 is a sectional view of a fluid pump according to someembodiments;

FIG. 4 is an enlarged view of a fluid pump within the system accordingto some embodiments;

FIG. 5 is a view of a medical fluid treatment system according to someembodiments;

FIG. 6 is a view of a medical fluid treatment system according to otherembodiments;

FIG. 7 is a schematic representation of a controller of the systemaccording to some embodiments;

FIG. 8 is a main screen view of the user interface according to someembodiments;

FIG. 9 is a graphing screen view of the user interface according to someembodiments;

FIG. 10 is an alarm screen view of the user interface according to someembodiments;

FIG. 11 is an example of a manual screen of the user interface accordingto some embodiments;

FIG. 12 is an example of a valve dwelve screen of the user interfaceaccording to some embodiments;

FIG. 13 is an example of a locked screen of the user interface accordingto some embodiments;

FIG. 14 is an example of a normal run screen of the user interfaceaccording to some embodiments;

FIG. 15 is an example of a heater screen of the user interface accordingto some embodiments;

FIG. 16 is an example of an error screen of the user interface accordingto some embodiments.

FIGS. 17 and 18 are examples of the modular system according to someembodiments.

DESCRIPTION OF EMBODIMENTS

The following description, numerous specific details are set forth suchas examples of specific components, devices, methods, etc., in order toprovide a thorough understanding of embodiments of the disclosure. Itwill be apparent, however, to one skilled in the art that these specificdetails need not be employed to practice embodiments of the disclosure.In other instances, well-known materials or methods have not beendescribed in detail in order to avoid unnecessarily obscuringembodiments of the disclosure. While the disclosure is susceptible tovarious modifications and alternative forms, specific embodimentsthereof are shown by way of example in the drawings and will herein bedescribed in detail. It should be understood, however, that there is nointent to limit the disclosure to the particular forms disclosed, but onthe contrary, the disclosure is to cover all modifications, equivalents,and alternatives falling within the spirit and scope of the disclosure.

The disclosure relates to devices and systems for medical fluidtreatment therapies, such as extracorporeal treatment therapies, toassist patients with severe organ deficiencies. The extracorporealtreatments may include but are not limited to CRRT, CVVH, CVVHD, andCVVHDF. It will be understood that components (such as the blood pump)of the devices and systems, as well as the devices and systems in theirentirety, may be implemented into and/or with other medical fluidtreatment therapy or extracorporeal treatment systems and devices.According to embodiments, the system may automatically adjust theoperation in accordance with the other medical fluid treatment therapyor extracorporeal treatment systems and devices. These other devices mayinclude but are not limited to an ECMO device, cardiopulmonary bypassdevice, ventricular assist device, plasma exchange device, apheresisdevice, or hemoperfusion device.

According to embodiments, the disclosure may relate to medical fluidtreatment devices and systems capable of small volume fluid management.In some embodiments, the medical fluid treatment devices and systems mayprovide to CRRT therapy. In some embodiments, the medical fluidtreatment devices and systems may be capable of CVVH therapy. In otherembodiments, the medical fluid treatment devices and systems may becapable of CVVHDF therapy. In other embodiments, the medical fluidtreatment devices and systems may be capable of CVVHD therapy. Infurther embodiments, medical fluid treatment devices and systems may becapable of providing all CVVH therapy, CVVHD therapy, and CVVHDFtherapy.

Systems and Devices

In some embodiments, the systems and devices may include a modular fluidtherapy system. FIG. 1 shows an example of a schematic of a system 100according to some embodiments.

In some embodiments, the system 100 may include a medical fluid therapysystem 110. The system 110 may include a plurality of sensors and/ordetectors 112. In some embodiments, the sensors 112 may include but arenot limited to fluid sensors, temperature sensors, and operation sensorsand detectors. The systems may also include additional sensors not shownor described below.

According some embodiments, the fluid sensors configured to detect ormeasure the fluid characteristics of a fluid along the flow paths. Thefluid characteristics include but are not limited to pressure of a fluidflowing through a path, the flow characteristics of the fluid flowingthrough a path, such as flow rate, the volume of the fluid passingthrough a path, or combination thereof. The fluid sensors may includebut are not limited to a flow meter, a pressure sensor, a volume sensor,or a combination thereof. It will be understood that the fluid sensorsdescribed with respect to the systems may be of the same or differenttype. The sensors may be of any known sensors. The fluid sensors may bedisposed within the system to detect or measure the fluidcharacteristics of the blood flowing through the system including butare not limited to the blood entering the system and exiting thepatient, the blood entering the hemofilter, and the blood exiting thesystem and entering the patient. The fluid sensors may also be disposedwithin the system to detect or measure the fluid characteristics of theultrafiltrate, replacement fluid, or dialysate flowing through thesystem including but are not limited to the ultrafiltrate or useddialysate exiting the hemofilter and/or collected, the replacement fluidexiting the system and entering the patient, and the dialysate enteringthe hemofilter

In further embodiments, the sensors 112 may further include at leastsensor and/or detector configured to determine/detect the temperature ofthe fluid flowing through the system. The sensor and/or detector may beany known temperature sensor. The sensor and/or detector may be incombination with a heater.

According to some embodiments, the sensors 112 may include at least onesensor and/or detectors that may be used to determine the operationstatus of the system. The sensors and/or detectors may provide feedbackof the systems and devices according to the embodiments. The sensorand/or detector may be any known detector. The detectors may beconfigured to detect the presence of certain fluids, for example, thepresence of blood, ultrafiltrate, or air.

In some embodiments, the system 110 may include at least one pumpconfiguration 114. According to some embodiments, the pump configurationmay include at least one pump and a corresponding valve. The valves maybe configured to control the fluid direction through the systems. Insome embodiments, the valves may be controlled electronically. In otherembodiments, the valves may be controlled mechanically. The valves mayinclude but are not limited to pinch valves. The pinch valves may bemade of a sterile, biocompatible material such as polished acrylic. Thevalves are further described below with respect to the figures. Infurther embodiments, the pump configurations 114 may include a pluralityof fluid pumps along the paths. The fluid pumps may be configured orstructured to pump a small volume of fluid. The pumps may be controlledcollectively with the valves to move the fluid by a controller. In someembodiments, the pump configurations 114 may include a motor to actuatethe pump.

The system 110 may further include at least one controller 116configured to control the sensors 112 and pump configuration 114.According to some embodiments, the system 110 may include a plurality ofcontrollers. The system 110 may include a main controller and a separatecontroller for each motor provided for the pump configuration 114. Inother embodiments, the system 110 may include a separate controller foreach motor provided for the pump configuration 114.

According to some embodiments, the controller may be a CPU. The CPU maybe any known may be one or more of any known central processing unit,including but not limited to a processor, or a microprocessor. The CPUmay be coupled directly or indirectly to memory elements. The memory 118may include random access memory (RAM), read only memory (ROM), diskdrive, tape drive, etc., or a combinations thereof. The memory may alsoinclude a frame buffer for storing image data arrays. The operatingstatus detected by the sensors and/or detectors 112 may be stored in thememory 118. The processes of the system (described below) maybeimplemented as a routine that is stored in the memory 118.

According to some embodiments, the system 100 may further includedisplay system 120. In some embodiments, the display system 120 may beintegrated with the medical fluid therapy system 110. In otherembodiments, the display system 120 may be separately connectable to themedical fluid therapy system 110. FIGS. 17 and 18 show examples of asystem having an integrated modular configuration and/or a separatedisplay unit.

In some embodiments, the display system 120 may include an input device122 and a display device 124. In some embodiments, the input device 122may include but is not limited to a touch screen interface, a keyboard,a mouse and trackball. The display device may be any known displaydevice.

In further embodiments, the display device 120 may optionally include acontroller 126 and a memory 128. According to some embodiments where thedisplay system 120 may be integrated with the medical fluid therapysystem 110, the display system 120 and the medical fluid therapy system110 may share at least one controller and memory. In furtherembodiments, the display system 120 may include a separate controllerand memory.

According to some embodiments, the controller 126 may be a CPU. The CPUmay be any known may be one or more of any known central processingunit, including but not limited to a processor, or a microprocessor. TheCPU may be coupled directly or indirectly to memory elements. The memory128 may include random access memory (RAM), read only memory (ROM), diskdrive, tape drive, etc., or a combinations thereof. The memory may alsoinclude a frame buffer for storing image data arrays. The operatingstatus detected by the sensors and/or detectors 112 may be stored in thememory 128. The processes of the system (described below) maybeimplemented as a routine that is stored in the memory 128.

According to further embodiments, at least one of the medical fluidtherapy system 110 and the display system 120 may be connected to anetwork 130. According to some embodiments, the integrated system of themedical fluid therapy system 110 and the display system 120 may beconnected to a network. In further embodiments, one or both of themedical fluid therapy system 110 and the display system 120 may beconnected to a network. The network connection may be a hard wired orwireless connection to a network, for example, a local area network, orthe Internet. According to some embodiments, the network may be ahospital network so the operation notes of the system 100 may be storedin the electronic medical record for the patient.

In some embodiments, all components or some of the components of thesystem 100 may be further connected directly (via wired connections) toanother medical treatment therapy device, including, but not limited to,ECMO. In further embodiments, the readings may be transmitted viawireless network connection to other devices.

These components and operation of the system are described further belowwith respect to the figures.

Fluid Pump Housing

FIG. 3 shows a sectional view of a fluid pump 300 according to someembodiments. According to some embodiments, the fluid pump 300 mayinclude a housing 310. In some embodiments, the housing 310 may includeat least one section. In some embodiments, the fluid pump 300 mayinclude a first section 320 and a second section 350.

The first section 320 (may also be referred to as a fluid or bloodcompartment) may include a fluid chamber 322. The fluid chamber 322 maybe a membrane configured to hold the fluid entering the pump. Thechamber may be made of a flexible material, such as Gum Rubber. Thechamber 322 may include at least two conduits: a first conduit (or inletconduit) for fluid entering the pump and a second conduit (or outletconduit) for fluid exiting the pump.

In some embodiments, the chamber 322 may be fixedly attached to and/orconfined within the housing 310. The chamber 322 may include an uppersurface 321 and a lower surface 323. The upper surface 321 of thechamber 322 may be bordered by a cap 330. The cap 330 may extend over aportion or the entire upper surface 321. In some embodiments, the cap330 may be a rigid cap. In further embodiments, the cap 330 may befixedly attached to the housing 310 by a fastener 332. In someembodiments, the fastener 332 may be a locking ring. In otherembodiments, the fastener may be any known fastener.

In some embodiments, the cap 330 may include at least one connector oradapter for tubing. In some embodiments, the connector or adapter may bea port. In further embodiments, the cap 330 may include a connector oradaptor for each of the fluid conduits of the fluid chamber. In someembodiments, the cap 330 may include a first connector 334 and a secondconnector 336. In some embodiments, the connectors 334, 336 may be anyknown female luer lock posts.

The connectors may be positioned on the cap 330 as mirror images of eachother. Each of the connectors may be in fluid connection with therespective fluid conduits of the fluid chamber 322. The connectors mayoverlap the respective fluid conduit so that the tubing is in fluidconnection with the respective fluid conduit and may be configured toallow fluid to flow through the fluid chamber 322.

In some embodiments, the first section 320 may further include a cavity324. The cavity 324 may be configured to fixedly hold an incompressiblefluid or material. In some embodiments, the cavity 324 may be filledwith saline. The cavity 324 may be below the chamber 322 and border thelower surface 323.

As shown in FIG. 3, the first section 320 may have a surface 326 thatextends outwardly from the housing 310. The surface 326 may shaped likea flange. The second section 350 may have a surface 356 that extendsoutwardly from the housing 310. The surface 356 may also be shaped likea flange. The surfaces 326 and 356 may be of corresponding shape andsize.

In some embodiments, the fluid pump housing 310 may further include adiaphragm 340. In some embodiments, the diaphragm 340 may be disposedbetween the first section 320 and the second section 350. In someembodiments, the diaphragm 340 may be fixedly attached to the housingbetween the first and second sections of the pump. The diaphragm 340 maybe made of an elastomeric or flexible material, such as neoprene.Preferably, the diaphragm 340 is made of a material that is able tosustain a prolonged lifetime when repeatedly flexed. The diaphragm 340may be a rolling diaphragm. The diaphragm 340 may have a flange designwith a moldable o-ring that can be positioned between the first andsecond section. This configuration maintains proper orientation of amechanical actuator 360 when attached to the diaphragm 340. Thediaphragm 340 may include a surface 342 that may be configured to flexor move upon exertion of force by the mechanical actuator 360. In someembodiments, in resting (first) position, the diaphragm 340 has anascending convolution into the section. The surface 342 extends in thesecond section substantially parallel to the cap 330.

In some embodiments, the diaphragm 340 may be configured to move fromthe resting position based on the movement of the mechanical actuator.The diaphragm 340 may be configured to move to second and thirdpositions. In the second position, when the mechanical actuator 360 ismoved away from the chamber 322, the surface 342 of the diaphragm 340may be positioned further away from the cap 330 in the second section350. In the third position, when the mechanical actuator 360 is movedtoward the chamber 322, the surface 342 of the diaphragm 340 may bemoved toward and into the first section and thus positioned closer tothe cap 330. The surface 342 extends in the housing 310 substantiallyparallel to the cap 330 in the second and third positions.

The second section 350 of the fluid pump may include a mechanicalactuator 360 configured to drive the diaphragm 340. In some embodiments,the mechanical actuator 360 may include a piston 362. In someembodiments, the piston 362 may be fixedly attached to the diaphragm 340by a fastener. The fastener 366 is a cynoacrylate. In some embodiments,the fastener 366 may include a rolling bearing connected to a connectingpin of the rod. In further embodiments, the pump may include a rod 364.In some embodiments, the piston 362 may be connected to the rod 364 by afastener, an adapter or connector 366. In some embodiments, the fastener366 may include a connecting pin 365 and a roller bearing 367 (shown inFIG. 4).

All or some of the components of the pump housing may be sterilized andintended for single use.

According to some embodiments, the first and second sections and the capmay be made of materials such as ACCURA® 60.

Fluid Pump Motor & Motor Housing

According to embodiments, the pump 300 may be actuated by a motor. Thepump housing 310 may be removably attached to a motor by an adapter orconnector. In some embodiments, the connector may be a rolling bearing.In some embodiments, the connector may be disposed at the end of the rod364. For example, the rod may include a connector 368 shown in FIG. 3.The connector may be a roller bearing. In other embodiments, theconnector may be placed on the piston.

In some embodiments, the motor mounts and connectors, such as rollerbearings, may be made of stainless steel. The connecting pins, rods andpistons may be made of materials, such as Somos® NeXt.

In some embodiments, the fluid management systems may further include amotor. In some embodiments, the systems may include a motor for eachpump included in the fluid management systems. In other embodiments, thesystems may include a motor for two or more pumps.

In some embodiments, the pump may be actuated by a motor to move thefluid along the fluid path or loop. To move the fluid along, the fluidchamber may be deflected by transferring a force through the cavity thatcontains the incompressible solution from the diaphragm on the bottomthat is driven by a piston. The motor may drive the mechanical actuator(piston and rod system). The driving of the actuator of the motor mayalso trigger the corresponding set of pinch valves allowing control offluid direction.

The piston subsystem may be similar to that of a reciprocating piston ina combustion engine. A flywheel mounted to the motor may rotateproviding periodic movement to a rod through a driving post and then onto a piston. The piston attached to a rolling diaphragm may transfer theforce to an incompressible fluid (saline) which will then cause thedeflection of the fluid chamber. The direction change from rotational tolinear may be accommodated via a jointed coupling at the base of thepiston attached to the rod. All motion may thereby be transferred to themembrane system.

In some embodiments, the motion of the mechanical actuator (the rod andpiston system) may be a controlled by a controller and a motor. Themotor may be a motor capable of being controlled by a main controller ora combination of controller system (such as an EtherNet/IP Drive) andmotor.

In some embodiments, the pump may be disposed between a set of valves.The movement of the fluid chamber may be collectively controlled withrespect with the valves and the motor. In particular, the deflection ofthe fluid chamber may provide a suction and expulsion of the fluid intoand out of the fluid chamber, respectively, when synchronously paired toa set of pinch valves. When the valve prior to the pump is open and thevalve after the pump is closed, the piston may be on the downstrokeproviding suction to pull the fluid into the chamber. Once the flywheelreaches bottom dead center (the piston moved as far away from the pump300), the valves state changes and the piston causes the fluid to beexpelled from the chamber. When the valve prior to the pump is closedand the valve after the pump is open, the piston may be on the upstrokeproviding force to move the fluid out of the chamber.

The configuration of the valves and pump allow for the reduction offluid volume by not having to pass an internal compartment in aninternal or pass-through type valve.

FIG. 4 shows the pump 300 according to embodiments disposed within thesystem connected to a motor 400. As shown in FIG. 4, the motor 400 mayfurther include a plurality of motor mounts 410. Although two motormounts are shown in the figure, the system may include any number ofmounts. The motor 400 may include a cam shaft 412 that is connected tothe rod 364. The rod 364 may be connected via connector 368. Theconnector may be a roller bearing. The cam shaft may have acorresponding shape to the connector. The motor may have an encoder toallow for a closed loop feedback control system.

In some embodiments, the fluid management systems may further include apump receiving member 420 for each pump of the system. According to someembodiments, the pump receiving member may be made of materials such asACCURA® 60. Each pump receiving member may be structured and configuredso that the pump has no remaining degrees of freedom to allow for arigid system. The pump 300 may be disposed within the receiver. The pumpreceiving member may also be structured and configured to prohibitrotational motion. The receiver 420 may have a recess 422 thatcorresponds to the shapes of the extending surfaces of the first andsecond sections of the pump 300 (e.g., the flanges of the pump 300) sothat the rotational motion is prohibited. The pump 300 may further besecured into position by fasteners, such as screws.

Fluid Circuits or Loops

According to some embodiments, the components of the devices and systemsmay be configured or designed to have a plurality of fluid treatmenttherapies. The fluid treatment therapies may be performed by fluidcircuits or loops (paths). The devices and systems may include anynumber of fluid circuits or loops. The number of fluid circuits or loopsof the devices and systems may be modified according to the fluid needsand functions needed for treatment of the patient. For example, thepatient may not require the therapies provided by all of the fluidcircuits or loops.

In some embodiments, the devices and systems may be configured ordesigned to have any combination of the following fluid circuits orloops: a blood loop, a replacement fluid loop (CVVH mode), a dialysateloop (CVVDH mode), and an offset loop. FIG. 2 shows an example of asystem 200 that includes a blood loop 220, a replacement fluid loop 240,a dialysate loop 270, and an offset loop 280.

The blood loop 220 may be a closed-loop path of blood 210 that iscirculated out of a patient 202, filtered, replenished, and returned tothe patient. The replacement fluid loop 240 may be the closed-loop pathwhere the waste products from the blood are extracted and replaced withthe substantially the same amount of a prescribed replacement fluidduring the CVVH mode. The dialysate loop 270 may be the closed-loop pathwhere dialysate is added to the hemofilter for extraction of the wasteproducts from the blood during the CVVDH mode. The offset loop 280 maybe the closed-loop path that is configured to allow an adjustment of thevolume of replacement fluid by the clinician.

The blood loop 220 may include at least one fluid sensor 222 forsensing, detecting or measuring the flow characteristics or pressure, orcombination thereof, of the blood 210 leaving the patient. In furtherembodiments, the blood loop 220 includes at least a first valve 224, asecond valve 228, and a fluid pump 226. The first valve 224, the secondvalve 228, and the blood pump 226 may be collectively controlled (by acontroller) to move the blood 210 through the fluid pump 226 like theembodiments described above.

In some embodiments, the fluid pump 226 may be configured to managesmall volumes of blood. In some embodiments, the fluid pump 226 maycorrespond to the fluid pump 300 shown in FIG. 3 (described above). Inother embodiments, the fluid pump 226 may correspond to other knownfluid pumps.

The blood loop 220 may further include a hemofilter 232. The hemofilter232 may be a semi-permeable membrane that provides a system by whichtoxins from the blood can be removed via a method of convective drag ordialytic clearance. The hemofilter 232 may include a plurality of ports.In some embodiments, the hemofilter 232 may include at least a bloodinput, a blood output port, a port for ultrafiltrate/dialysate output.In further embodiments, the hemofilter 232 may further include adialysate input. The hemofilter 232 may be any known commerciallyavailable hemofilter. The blood loop may further include a sensor 230before the hemofilter 232 and a sensor 234 after the hemofilter.

After the blood 110 exits the fluid pump 226 via valve 228, the bloodflows through or by the sensor 230 before flowing through the hemofilter232. The sensor 232 may be configured to detect or measure the fluidcharacteristics of the blood entering the hemofilter. The blood exitingthe hemofilter may then flow through or by sensor 234 that measures thefluid characteristics of the blood exiting the hemofilter. The enteringand exiting measurements may be compared by the system to determine theoperation status of the hemofilter. If a malfunction or deterioration ofthe operation of the hemofilter is determined, the system may trigger analarm (described further below).

In the CVVH therapy mode, as blood is pumped through the hemofilter, thetoxins removed from the blood (as a result of the radial pressure)result in the creation of an ultrafiltrate through the pores in themembrane. The ultrafiltrate may then exit the hemofilter via theultrafiltrate/dialysate output and flow to the ultrafiltrate collectionreservoir or bag 250. In the CVVHD therapy mode, as blood is pumpedthrough the hemofilter, dialysate enters the hemofilter via thedialysate input and is pumped through the hemofilter in the oppositedirection of the blood flow on the opposite side of the membrane of thehemofilter. The pressures and dialysate remove the toxins from the bloodand the toxins are thereby added to the dialysate through the pores inthe membrane. The dialysate may then exit the hemofilter via theultrafiltrate/dialysate output and flow through the dialysate fluid loop170.

The systems may further include an air detector 236 and a third(emergency) valve 238. The air detector 236 and emergency valve 238 maybe disposed in the blood loop directly before the blood returns to thepatient. The air detector 236 may be any known air detector. The airdetector 236 may use ultrasonic waves to determine whether there are anypotentially hazardous air bubbles in the tubing before the blood returnsto the patient. The tubing may be simply placed in the air detector anddoes not require any direct interaction with the blood. Upon sensing anysignificant amounts of air in the blood loop, the system may trigger andalarm and immediately prohibit any further flow by activating theemergency valve 238 until the loop has been purged of air. During theprime sequence, the air detector may also be disabled to allow for fluidto propagate the system. The prime sequence may be conducted withouthaving a patient coupled to the system.

During the CVVH therapy mode, according to some embodiments, the systemsmay operate a replacement fluid loop 240. The ultrafiltrate 212 exitingthe hemofilter 232 may enter the replacement fluid loop 240 toward theultrafiltrate reservoir 250. The replacement fluid loop 240 may includea blood detector 242. The blood detector 242 may be any known blooddetector. The blood detector 242 may be placed in the replacement fluidloop 240 after the hemofilter 232. The tubing may be run through thedetector 242 without interacting with the ultrafiltrate. The blooddetector 242 may be configured to detect the operation status of thehemofilter 232. For example the blood detector 242 may be configured todetect color changes in the ultrafiltrate exiting the hemofilter 232.Based on the detection, the system may be configured to trigger an alarmalerting personnel that there may be a hemofilter operation error, suchas rupture in the hemofilter that would indicate a need to changehemofilters.

The replacement fluid loop 240 may include a fluid balance system. Thefluid balance system may be configured so that the volume of replacementfluid is added from the replacement fluid reservoir 260 is the same asor substantially the same volume of ultrafiltrate removed from theblood. In some embodiments, the fluid balance system may include twofluid pumps that are individually controlled to be offset of each other.The pumps may be controlled so that the motions are directly opposite ofeach other. By setting the two pistons motion directly opposite of eachother, (substantially or near) perfect fluid balance may be achieved.The first pump may receive the ultrafiltrate that exited the hemofilterand the second pump may receive the replacement fluid that will replacethe ultrafiltrate removed from the blood. As shown in FIG. 2, thereplacement fluid loop 240 may include pump 246 for pumping theultrafiltrate to the ultrafiltrate (collection) reservoir 250 and pump266 for pumping the replacement fluid from a replacement fluid reservoir260.

The system may further include a set of valves for each of the pumps. Asshown in FIG. 2, the pump 246 may be between (fourth) valve 244 and a(fifth) valve 248. The pump 246 may be configured to pump theultrafiltrate 212 removed via the hemofilter 232 to the ultrafiltratecollection reservoir 250. The pump 266 may be between (sixth) valve 262and (seventh) valve 264. The pump 266 may be configured to pump the sameor the substantially the same volume of replacement fluid 213 from thereplacement fluid reservoir 260 as the volume of ultrafiltrate 212collected in the ultrafiltrate collection reservoir 250. Each set ofvalves and the pump may be collectively controlled (by a controller) tomove the blood through the respective fluid pump like the embodimentsdescribed above.

In some embodiments, the fluid balance system may include two motorsthat each controls one of the two pumps. In other embodiments, the fluidbalance system may include one motor that separately controls the twopumps. In these embodiments, a controller may individually control thecollective configuration of set of valves and pump for the replacementfluid and the collection configuration of set of valves and pump for theultrafiltrate. In some embodiments, the fluid balance system may includethe same or different pumps.

In some embodiments, both or one of the pump housings of the fluidbalance system may correspond to the pump housing shown in FIG. 3. FIG.5 shows an example of a system 500 having a fluid balance system 510that includes two pump housings like the housing shown in FIG. 3. Asshown in FIG. 5, the fluid balance system 510 may include two pumps 512and 514. These pumps 512 and 514 may be respectively connected topistons 532 and 534. The pistons of these pumps may be linearly offset.For example, one of the pistons 532 and 534 may have a starting positionin the uptake position and the other one of the pistons 532 and 534 mayhave a starting position in the opposite position, the downtakeposition.

FIG. 5 shows the two pumps 512 and 514 connected to a single shaft 530connected to a single motor 550. The motor may be capable if andconfigured to drive the two pumps simultaneously, thereby a single drivesystem powers two mechanically coupled pumps.

According to some embodiments, the shaft 530 may include a first gearthat interfaces and meshes with a second gear. The second gear may beconfigured to serve two purposes—the first is to transfer the rotationalmotion of the motor to the pump system described in the blood loop, thesecond is to concurrently transfer rotational motion to a shaft by whichanother flywheel is connected on the opposing end. The shaft may besupported via two roller bearing stands mounted to the enclosure. Byhaving the second gear and flywheel mounted in such a fashion on acommon shaft whereby the driving posts are 180° out of phase respectiveto each other, a perfect or near perfect fluid balance may be achieved.When the flywheel controlling the ultrafiltrate is on an upstroke, theflywheel controlling the replacement fluid will be in the exact sameposition on a downstroke.

These embodiments also address the common issue associated with theproduction of ultrafiltrate through a hemofilter—the rate of productionof ultrafiltrate. Due to the nature and efficiency of hemofilters, theinitial ultrafiltrate production rate at the beginning of a cycle may bequite brisk and be higher than desired. To counteract this phenomenon,the coupled pump system according to may provide fluid balance byallowing the system to run as intended. In other embodiments, the valvesmay be actuated to further counteract this phenomenon. The valves may beactuated via the control system to reduce the flow to a prescribedamount. The backpressure of the system will prevent the flow fromcontinuing down the path. Positive pressure will not be created bynature of obstructed tubing path providing a controlled closed system.By using the same pump system as the blood pump, costs may also bereduced and uniformity among subsystems may be allowed.

In other embodiments, two pumps 612 and 614 may be attached to pistonsin a V-type configuration of the pump systems with a single motorproviding the driving force through a crankshaft to two pistons as shownin FIG. 6. The pump housing may be same as or similar to the pumphousing shown in FIG. 3.

In other embodiments, the fluid balance system may be any known fluidbalance system, such as the system described in U.S. application Ser.No. 12/663,253, which is incorporated in its entirety.

In some embodiments, the replacement fluid loop 240 may include a fluidheater 268. The fluid theater 268 may be any known fluid heater. Thefluid heater 268 may address the thermal concerns in the blood loop andreplacement fluid loop. Because of convective heat transfer between theblood, tubing, and ambient air temperatures, a fluid heater may beplaced after the hemofilter 232 and before the patient 202. The heater268 may be configured to heat replacement fluid 213 that will be mixedwith blood 210 directly before return to the patient 202. The heater 268may also be configured to maintain the standard core temperature withboth upper and lower limits to prevent hypothermia or hyperthermia inthe patient.

The replacement fluid loop 240 may further include at least onetemperature monitor detector or system 269. The temperature monitoringsystem 269 may be combined or separate from the fluid heater 268. Thetemperature monitoring system may include at least one of knowntemperature sensor. The temperature monitoring system may be disposed atone or a plurality of locations along the replacement fluid loop toprovide a closed loop feedback system to allow for the device to adjustfluid temperature and process temperature data in real time. The heatermay be isolated from the loop for the benefit of sterility. Thereplacement fluid 213 may be heated convectively when passing through aheated area while still contained in its tubing.

During the CVVHD therapy mode, according to some embodiments, thesystems may operate a dialysate fluid loop 270. During this mode, thedialysate or replacement fluid 213 may be pumped from the replacementfluid or dialysate reservoir 260 via the pump 266 and valves 262 and 264configuration. Although the figures show that the dialysate 214 ispumped from the same reservoir from which the replacement fluid ispumped for the fluid balance loop, the system, in other embodiments, mayinclude a separate reservoir for the dialysate. The controller controlsthe flow rate and volume of the dialysate removed from the reservoir viathe pump configuration. The dialysate 214 is then pumped to thehemofilter 232. The dialysate 214 enters the hemofilter via a dialysateport. The hemofilter 232 then removes the toxins and disposes of thediscarded dialysate 215. In some embodiments, the hemofilter disposes ofthe discarded dialysate through the same flow path as discardedultrafiltrate. For example, the discarded dialysate 215 flows throughthe blood detector 242, the pump 246 via the operation of valves 244 and248, to the ultrafiltrate/dialysate reservoir 250 for collection.

According to some embodiments, the systems may also include an offsetloop 280. The offset loop may provide adjustability for any deviationsfrom the replacement fluid loop. For example, in certain conditions,clinicians may need to impose a positive or negative state of fluidbalance. The offset loop will provide this functionality.

In some embodiments, the offset loop 280 may include valves and pumpconfiguration similar to the blood loop. The offset loop 280 may includea (eighth) valve 282 and a (ninth) valve 286 and pump 284. The pump 284may be the same as or similar to pump shown in the figures. The pump 284and valves may be collectively controlled to control the volume ofreplacement fluid via the replacement fluid reservoir 260 to be added orremoved from the replacement fluid 213 to be provided to the patient202.

Configuration of Devices and Systems

In some embodiments, the system may be housed in a modular or portableunit. The modular unit may have housing configured to control sterilityof the system. For example the components of the system may be disposedat different self-contained sections of the housing. The self-containedsections may improve sterility of the system. The sections may beseparated by an overlay or surface. The surface may be made of a plasticor acrylic material.

In some embodiments, the housing may include a plurality of sections. Insome embodiments, the mechanical components and electronics of thesystem may be self contained and separated from the (single-use orreplaceable) items connected to the system via connectors and/oradapters. For example, the processing components such as controllers maybe provided underneath the mechanical components (such as the motor) ina self-contained section. The mechanical components may be furtherseparated from the single-use items (such as the pump and tubing) in aself-contained section. These items may include but are not limited tothe pump housing that may be connected to the motor within the housingas well as tubing that connects to the replacement fluid reservoirs andultrafiltrate (collection) reservoirs. According to some embodiments,the replacement fluid reservoirs and ultrafiltrate (collection)reservoirs may be external to the system housing and connected to thesystem via medical tubing.

FIG. 5 shows an example of the modular housing (with the tubing notshown).

In some embodiments, the housing may include adapters or connectorsconfigured for the connectable system components. The connectors may beconfigured to removably attach the connectable system components to thehousing or system so that the connectable system components can beconnected to the system during operation and may then later be removedand replaced with new components. In some embodiments, the components ofthe system may include connectors or adapters configured to receive theconnectable system components. For example, pinch valves 580 may eachinclude a connector for the tubing extending from the pumps. Thehemofilter 570 may also include a connector or receiver 572 to receive ahemofilter.

In some embodiments, the system 500 may include at least one pumpreceiving member 520. The pump receiving members 520 may be configuredto have a depression in a surface to receive each pump. FIG. 5 showsfour pump receiving members, one pump receiving member for each pump.The pump receiving members 520 may be configured to receive any pump ofthe system, for example, pumps 512, 514, 516, and 518. The pumps may befor the replacement fluid loop, as well as the pumps for the other loopsof the system. The pump receiving member 520 may be made of an acrylicmaterial that is capable of being sterilized. Although only a portion isshown, it would be understood that each pump receiving member 520 may bea part of a housing divider configured to separate and self-contain themechanical components, such as motors 550 and 552 from the connectablesystem components.

It will be further understood that the processing components, such ascontroller 560 may be further separated from the mechanical componentsby a self-containing layer 562.

According to some embodiments, a motor may drive to at least one pump.As shown in FIG. 5, the motor 550 may be connected to and drive thefluid balance system including pumps 512 and 514. The other pumps, 516and 518, configured for the blood and offset loops, may each beconnected to and be configured to be driven by motors 552 and 554,respectively.

Connectable/Disposable System Components:

According to some embodiments, the system may be configured to receivesingle use or disposable connectable items. In some embodiments, theseitems may be sterilized.

According to some embodiments, the items may include but are not limitedto the pump housing, tubing, and hemofilter. According to someembodiments, a portion or combination of the single use items may besold as kit.

In some embodiments, the kit may include at least one pump housing thatincludes all or portions of the pump housing shown in FIG. 3. The pumphousing will at least include a connector, such as roller bearing,configured to connect to a motor of the system. In further embodiments,the kit may include a plurality of pump housings. For example, in someembodiments, the kit may include one, two, three or four pump housings.In alternative embodiments, the kit may include additional pumphousings.

In further embodiments, the kit may include tubing for the system. Thetubing may be in addition to or in alternative to the pump housing. Insome embodiments, the kit may further or alternatively include a tubeframe. The tube frame including sections for disposing all or most ofthe tubing. The tubing may be configured as a part of the tube frame.

In further embodiments, the kit may include at least one connectorconfigured to connect the tubing and/or pump to the system.

In further embodiments, the kit may include a hemofilter. The hemofiltermay be in addition to or in alternative to the pump housing and tubing.

Control Module and Display

According to some embodiments, the display system may further include auser interface. In some embodiments, the instructions for user interfacemay be programmed and stored in the memory of the display system. Inother embodiments, the instructions for the user interface may beprogrammed and stored in the memory of the fluid therapy system. Infurther embodiments, the instructions for the user interface may beprogrammed and stored remotely and accessed by either or both thedisplay system and the fluid therapy system.

According some embodiments, the user interface may be programmed tocontrol or provide instructions to control the systems and devices ofthe disclosure. The user interface may control or provide instructionsto control the systems and devices of the disclosure based on inputsentered by the user into the user interface using an input device.According to embodiments, the controller(s) may control the systemaccording to the inputs.

According to the some embodiments, the inputs may include treatmentmode. Treatment modes may include but are not limited to CRRT, CVVH,CVVHD, and CVVHDF modes. One or a combination of the treatment modes maybe selected. In other embodiments, the inputs may further includeanother or adjunct medical fluid treatment therapy or extracorporealtreatment systems and devices (also referred to as other medical fluidtreatment therapy systems and devices) for which the system will be usedin conjunction. In some embodiments, the system may be connected to theother medical fluid treatment therapy systems and devices. In furtherembodiments, the controller may control the other medical fluidtreatment therapy systems and devices. These other devices may includebut are not limited to an ECMO device, cardiopulmonary bypass device,ventricular assist device, plasma exchange device, apheresis device, orhemoperfusion device. According to further embodiments, the inputs mayfurther include patient type, such as pediatric or adult.

The inputs may further include operating parameters. In someembodiments, the operating parameters may be specific to the mode,adjunct therapy, other connected devices, patient type, or anycombination thereof. In some embodiments, any or all of the operatingparameters may be stored for each mode, adjunct therapy, other connecteddevices, patient type, or any combination thereof. In furtherembodiments, the controller may automatically control all or any of theoperating parameters for the system based on the mode, adjunct therapy,other connected devices, patient type, or any combination thereofselected. In other embodiments, the user may input all or any of theoperating parameters for the mode, adjunct therapy, other connecteddevices, patient type, or any combination thereof selected.

According to some embodiments, the operating parameters may be inputtedor entered into the user interface using an input device such as akeyboard or a touch screen. In some embodiments, the operatingparameters may be entered on the main screen shown in FIG. 8, which maybe accessed via button 810. In some embodiments, the inputted operatingparameters may be adjusted during operation, for example, by selectingthe reset button.

According to some embodiments, the operating parameters may be enteredby selecting an operating parameter shown on the screen. In someembodiments, the operating parameters may include volumetric flow rates820 for several parameters. The flow rates may be set for any one orcombination of operating parameters. The operating parameters may,include, but are not limited to, blood 822, ultrafiltrate (UF) 824,replacement fluid (RF) 826, offset (UF-RF) 828, and dialysate 830. Insome embodiments, the volumetric flow rates may be inputted in mL/min.In further embodiments, the ranges for inputted flow rates may bepredetermined. Thee ranges may be based on the patient type, such as anadult or a pediatric. For example, the blood volumetric flow rate may belimited to the range of 0 to 150. The UF, dialysate, and offsetvolumetric flow rates may also be limited to a predetermined range. Infurther embodiments, users may be able to input a flow time in hours orminutes in time left field 840. The remaining flow time may also bedisplayed in that or a different field. The countdown may be helpfulindicator when the materials, such as the replacement fluid ordialysate, may be getting low.

The user may start delivering therapy via the systems according to theembodiments by selecting the power button. Once the system is power, thegraphical representation 850 of the operation status of the system maybe visible on the display screen. The operating status may include butare not limited to the status of the pumps in motion, valves opening andclosing, fluid volumes, status of blood and air detectors, patient exitpressure, filter enter pressure, patient enter pressure, heatertemperature, and time remaining. For example, the screen shown in FIG.15 shows an input screen for adjusting the heater temperature. While thedevice is running, flow rates may be adjusted and counters may be reset.

The user interface may include certain operation protocols when certainconditions, such as air or blood are detected. For example, operationprotocols may include automatically shutting down the machine andsetting an alarm condition. The alarm condition may be programmed sothat the condition must be cleared before the system will restart. Theoperating protocols may be manually bypass or modified based on theneeds of the user. In some embodiments, the operation protocols may notbe adjusted unless the user has higher level access, such asadministrator access to the user interface.

The user interface may further include at least one accessory screen.The screens may include but are not limited to graphing, alarms, prime,lock, heater, stroke, and manual. These screens may be accessible byfields or icons on 860 the top of each screen.

According to some embodiments, the controller may control the systembased on the operating parameters. The controller may also control thesystem based on the operation status of the system. FIG. 7 shows theschematic 700 of the control parameters for a controller 710. In someembodiments, the controller may control the system by transmittedoutputs 730 to the system. In further embodiments, the controller maycontrol a connected or adjunct therapy device(s) by transmitting outputs730 to the connected or adjunct therapy device(s).

In some embodiments, the outputs may be based on inputs 720 receivedregarding the operating status of the system. The outputs may be basedon the comparison of the received inputs to the prestored or inputtedoperating parameters.

The inputs 720 may be based on the sensors and/or detectors included inthe system. The sensors and/or detectors may include but are not limitedto fluid sensor(s) 722, detector(s) 724, and temperature sensor(s) 726.In other embodiments, the inputs may be received from other andadditional sensors and detectors from the system. In other embodiments,the inputs may be received from other systems, such as connected oradjunct therapy devices.

The controller may receive information from the fluid sensors 722. Theinformation may include but is not limited to the fluid characteristicsof the fluid(s) flowing through the system, such as blood, replacementfluid, ultrafiltrate, and dialysate. In some embodiments, the detectors724 may include but are not limited to the blood detector and airdetector. The information may receive information from the detectors724. The information may include but is not limited to the detection ofair in the blood or blood in the ultrafiltrate. In some embodiments, thetemperature sensors 726 may provide information regarding the fluidflowing through the system.

According to the inputs, the controller may transmit one or more outputsto the system. In other embodiments, the controller may transmit one ormore outputs to another system. In some embodiments, the outputs may betransmitted to hardware elements of the system. The hardware elementsinclude but are not limited to memory 732, pinch valve(s) 734, display736, replacement fluid heater 738, pump(s) 740, and protocols 742.

According to some embodiments, the controller may transmit theinformation received from the inputs to a memory device for storage. Infurther embodiments, the information received from the inputs may betransmitted to a network computer for storage. The controller may alsotransmit a record of any or all of the transmitted outputs, such as thecontrol instructions), to a memory or network computer for storage. Thecontroller may also transmit the information received from the inputs toa display device for display. In further embodiments, the controller maytransmit record of any or all of the transmitted outputs to a displaydevice for display.

The controller may also control the system based on the inputs. In someembodiments, the controller may control any one or combination of thepinch valve and pump systems based on the inputs. The controller maycontrol the operation status of the pinch valve and pump system. Theoperation status may include but is not limited to timing, dwell angle,the flow rate, and offset. In further embodiments, the controller maycontrol replacement fluid heater 738. The controller may cause theheater to increase or decrease the heat produced. In furtherembodiments, the controller may control the system according toprotocols when the controller receives inputs of certain conditions. Theprotocols may include but are not limited to automatically shutting downthe system, shutting down a component of the system, or activation of analarm.

According to some embodiments, the controller may also transmit theinformation received from the inputs and/or the record of the outputs toconnected or adjunct therapy devices.

According to some embodiments, the accessory screens may include agraphing screen, like the screen 900 shown in FIG. 9. The graphingscreen may allow the user to view the operating parameters of the systembased on date/time group process variables. These variables may includebut are not limited to volumetric flow rates, motor speed, and bloodpressures. The user interface may be programmed to process thesevariables to a SQL server database that could then be queried by anymedical record system. Parameters of interest could either be sampled atsome predetermined interval, such as an hourly or daily interval, or beevent driven like a process variable exceeding the alarm limit.

The display system may be connected to the local area network viaEthernet making remote viewing possible. This would enable others to seethe process variables using the graphing screen without having tophysically be in the patient's room. Someone else could, from adistance, trouble shoot a faulty detector and recommend correctiveaction.

The graphical trend shown in FIG. 9 may have any number of parametersfor simultaneous observation. The screen shows eight possible parameters910 but may be include additional parameters. The parameters may beprogrammed or selected to update every few seconds or zoom in and out atan area of interest. This will provide t the ability to perform realtime data acquisition. Also, this screen may be valuable and helpfulwhen troubleshooting the system, such as a faulty transducer or whencorrelating the effect of a pump speed change on filter differentialpressure.

The accessory screens may further include an alarm history screen and analarm summary screen. The alarms may be activated when the controllerdetermines based on the sensor or detectors that at least one componentof the system is not operating properly. The alarm history screen, anexample shown in FIG. 10, may provide access to all alarms that haveever occurred. The alarm summary screen may be configured to displayactive alarms which have not been acknowledged. When there is an active,the user may be notified. For example, the smiley face icon, as shown inthe main screen 800, in the Alarms button, may change into a flashingred mad face to indicate there is a problem. Acknowledging a criticalalarm that has shut down the unit may allow the system to be restarted;however, unless the fault is corrected it will just shut down again.Faults may be predefined or defined according to the lower and upperlimits of the process variables being exceeded.

The accessory screens may further include a manual screen, as shown inFIG. 11. The manual screen may allow access for manual operation andconfiguration of the system. This screen may be password or credentialprotected for a higher administrator, repair, maintenance, or biomedicalengineering use. From this screen, the user may manually override theoperation of the system. For example, a user may manually disable theair and blood detector, bypass the pressure transmitters, and change thedwell angle on the valve opening and closing for example. The user maybe able to enter set points for pump volumes and alarm pressures.

The accessory screens may further include a valve dwell screen as shownin FIG. 12. The valve dwell screen may display the dwell angle of eachvalve in operation in the system.

The accessory screens may further include a locked screen as shown inFIG. 13. This screen may display information but will not allow changesto the current therapy to unauthorized users. The screen may be byprotected by a password or specific credentials. The credentials mayinclude but are not limited to an access badge, smart card, biometricdevice, bar code. In order to make changes to therapy (by unlocking thescreen and providing access to the main screen, for example), the usermay have to enter or provide a correct password or proper credentials.

An example of main screen for when the system is operating properly isshown in FIG. 14. An example of when there is an error, for example,with the dialysate is shown in FIG. 16.

While various embodiments of the disclosure have been described, thedescription is intended to be exemplary rather than limiting and it willbe appeared to those of ordinary skill in the art that may moreembodiments and implementations are possible that are within the scopeof the disclosure.

What is claimed:
 1. A method for moving a fluid along a fluid path,comprising: flowing a fluid into a fluid chamber disposed in a firstsection of a fluid pump, the fluid chamber including a lower surface;driving an actuator to move a diaphragm toward the fluid chamber intothe first section of the fluid pump to transfer a force through a cavityfilled with an incompressible fluid or material to the fluid chamber;and expelling the fluid from the fluid chamber when at least the lowersurface is deflected by the force.
 2. The method according to claim 1,wherein the first section includes the fluid chamber and the cavity, thecavity being disposed between the fluid chamber and the diaphragm. 3.The method according to claim 2, wherein the lower surface includes aflexible material.
 4. The method according to claim 1, furthercomprising: opening a first valve and closing a second valve to flow thefluid into the fluid chamber; and closing the first valve and openingthe second valve to expel the fluid from the fluid chamber.
 5. Themethod according to claim 4, wherein: the actuator is upstroke when thefirst valve opens and the second valve closes; and the actuator isdownstroke when the second valve opens and the first valve closes. 6.The method according to claim 1, further comprising: controlling a setof valves and the actuator to control movement of the fluid through thefluid chamber.
 7. The method according to claim 6, further comprising:controlling flow rates of the fluid flowing through the pump and anangle of the valves according to an operating status.
 8. The methodaccording to claim 1, further comprising: rotating a flywheel to drivethe actuator to linearly move the diaphragm.
 9. The method according toclaim 1, further comprising: flowing another fluid into a fluid chamberof another fluid pump when the fluid is expelled from the pump.
 10. Themethod according to claim 9, wherein a volume of the other fluid flowedinto the fluid chamber of other pump and a volume of the fluid expelledfrom the fluid chamber of the fluid pump are substantially similar. 11.The method according to claim 1, wherein the diaphragm is disposeddirectly below the cavity.
 12. A method for moving a fluid along a fluidpath, comprising: driving an actuator downstroke; opening a first valveand closing a second valve; flowing a fluid through the first valve intoa fluid chamber disposed in a first section of a fluid pump, the fluidchamber including a lower surface; driving the actuator upstroke to movea diaphragm toward the fluid chamber into the first section of the fluidpump to transfer a force through a cavity filled with an incompressiblefluid or material to the fluid chamber; closing the first valve andopening the second valve; and expelling the fluid from the fluid chamberthrough the second valve when at least the lower surface is deflected bythe force.
 13. The method according to claim 12, wherein the firstsection includes the fluid chamber and the cavity, the cavity beingdisposed between the fluid chamber and the diaphragm.
 14. The methodaccording to claim 13, wherein the lower surface includes a flexiblematerial.
 15. The method according to claim 12, further comprising:controlling flow rates of the fluid flowing through the pump and anangle of the valves according to an operating status.
 16. The methodaccording to claim 12, further comprising: rotating a flywheel to drivethe actuator to linearly move the diaphragm.
 17. The method according toclaim 12, further comprising: flowing another fluid into a fluid chamberof another fluid pump when the fluid is expelled from the pump.
 18. Themethod according to claim 17, wherein a volume of the other fluid flowedinto the fluid chamber of the other pump and a volume of the fluidexpelled from the fluid chamber of the fluid pump are substantiallysimilar.
 19. The method according to claim 12, wherein the diaphragm isdisposed directly below the cavity.